Search Results

The Ceribell Seizure Detection Software is intended to mark previously acquired sections of EEG recordings in patients greater or equal to 1 year of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection Software also provides notifications to the user when detected seizure prevalence is "Frequent", "Abundant", or "Continuous, per the definitions of the American Clinical Neurophysiology Society Guideline 14. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Section notifications will be shown to a user. The Ceribell Seizure Detection Software does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a training expert.

The Ceribell Seizure Detection Software is a software-only device that is intended to mark previously acquired sections of EEG recordings that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces.

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording. The Ceribell Instant EEG Headband is comprised of the following components: - An elastic fabric headband - A cable attached to the headband to allow connection to an EEG acquisition/recording device - 10 electrode assemblies, each consisting of the following: - Passive Silver/silver-chloride electrode - Reservoir filled with conductive electrolyte gel - Mechanism for dispensing gel onto patient scalp - Scalp-contacting prongs to prepare scalp for electrode contact

The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14. The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The device is not intended for use in Epilepsy Monitoring Units.

The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device. The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the 10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm.

The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device. The Ceribell Instant EEG Headcap is comprised of the following components: - An elastic fabric headcap - An elastic chin strap - A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes - A cable attached to the headcap to allow connection to an EEG acquisition/recording device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 2 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K191301) for EEG acquisition and recording. The Ceribell Instant EEG Headband is comprised of the following components: - An elastic fabric headband - A cable attached to the headband to allow connection to an EEG acquisition/recording device - 10 electrode assemblies, each consisting of the following: - Passive Silver/silver-chloride electrode - Reservoir filled with conductive electrolyte gel - Mechanism for dispensing gel onto patient scalp - Scalp-contacting prongs to prepare scalp for electrode contact

The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment. Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is "Frequent," "Abundant," or "Continuous," per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

The Ceribell Pocket EEG Device is a previously cleared EEG monitoring system which includes a portable 8-channel system that is being upgraded in this 510(k) notification K191301 to include a seizure detection module. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels. The device may be used with any scalp EEG electrodes, and the system includes the following components: - Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. - Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. - Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled. - EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a computer. The EEG Recording Viewer Software includes a Seizure Detection software module that assists qualified users in reviewing and annotating EEG by marking previously acquired sections of EEG that may correspond to electrographic seizures.

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 6 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363) for EEG acquisition and recording. The Ceribell Instant EEG Headband is comprised of the following components: - An elastic fabric headband - A cable attached to the headband to allow connection to an EEG acquisition/recording device - 10 electrode assemblies, each consisting of the following: - Passive Silver/silver-chloride electrode - Reservoir filled with conductive electrolyte gel - Mechanism for dispensing gel onto patient scalp - Scalp-contacting prongs to prepare scalp for electrode contact

The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.

The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG monitoring system. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels, and may be used with any scalp EEG electrodes. The Device includes the following items: - Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. . - Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ● - . Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled. - EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.